Kinesiological Taping and Aerobic Exercise in Women With Primary Dysmenorrhea:

Primary Dysmenorrhea Clinical Trial

Official title:

The Effects of Kinesiological Taping and Aerobic Exercise in Women With Primary Dysmenorrhea: A Randomized Single-Blind Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04856280
• Other study ID #: KinesioExercisePD2021
• Status: Completed
• Phase: N/A
• Start date: November 22, 2019
• Est. completion date: July 20, 2020

Study information

• Verified date: April 2021
• Source: Istanbul Medipol University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Dysmenorrhea is defined as the pain and discomfort of women during the menstrual period. Kinesiological taping (KT) and aerobic exercise (AE) are effective methods for dysmenorrhea. The purpose of this study is to investigate the effects of KT and AE on pain, attitude, depression, and quality of life in women with dysmenorrhoea. Forty-five women with dysmenorrhea wıll randomly be divided into three groups as KT group (n=15), AE group (n=15) and control group (n=15). In KT Group, 6 sessions of KT will be applied, starting on the 14th day of the menstrual cycle and 2 times per week for 3 weeks until the end of the cycle. In the AE group, walking and climbing stairs will be given during the menstrual cycle, 3 days a week, 45 minutes. No application will be applied to the control group. All groups will be evaluated with Beck Depression Scale (BDS), Mcgill Pain Questionnaire (MPQ), Menstrual Attitude Scale (MAS), and Short Form- 36 (SF-36) before and after the intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: July 20, 2020
• Est. primary completion date: June 14, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 30 Years

Eligibility

Inclusion Criteria:

• Being in the age range of 15-30
• Not being married
• Women with abdominal pain during menstruation 5 and above according to the Visual Analogue Scale.
• Women whose menstrual cycle has started and those whose cycle continues.

Exclusion Criteria:

• Endometriosis and adenomyosis
• Myoma
• Endometrial polyp
• Previous pelvic infections
• Intrauterine device use
• Venous congestion in the internal genital organs

Related Conditions & MeSH terms

• Aerobic Exercise
• Dysmenorrhea
• Kinesics
• Primary Dysmenorrhea

Intervention

Behavioral:
• Kinesiological taping
In KT Group, 6 sessions of KT were applied, starting on the 14th day of the menstrual cycle and 2 times a week for 3 weeks until the cycle ended.
• Aerobic exercise
In the AE group, walking and climbing stairs were given during the menstrual cycle, 3 days a week, 45 minutes.

Locations

Country	Name	City	State
Turkey	Istanbul Medipol University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mcgill Pain Questionnaire	This questionnaire consists of 11 words to determine the sensory state of pain, and 15 words related to the quality of pain in total, consisting of 4 different words to determine its affective aspect. In addition, the pain intensity felt during measurement is measured by Visual analog Scale (VAS), and the total pain intensity assessed is measured by a 6-point Likert-type scale. In this scale, "0" is defined as no pain, "5" is defined as unbearable pain.	4 weeks
Primary	Menstrual Attitude Scale	The scale was prepared based on the theory that there may be versatility in menstrual attitudes, positive attitudes may occur as well as negative, and expectations that may occur according to physiological and emotional symptoms before or during menstruation may be effective in the behaviors shown in this period. Menstrual Attitude Scale (MAS) contains 33 items to measure the positive and negative attitudes of menstruation. MAS has 5 subscales such as the menstruation as a weakening phenomenon (12 no pain, unbearable pain, 32 items), the menstruation as a disturbing phenomenon (6 items), the menstruation as a natural phenomenon (5 items), the predicting/sensing that there will be menstruation (5 items), and the denying the effects of menstruation (7 items). The scale is of 5-point Likert type. The high average score of the subscales shows that the attitude towards menstruation is "positive"	4 weeks
Secondary	Beck Depression Scale	It is a test containing 21 items that the person evaluates himself. It measures the symptoms seen in depression such as emotional, cognitive and motivational. The items determine a behavioral feature related to depression. Items are numbered from 0 to 3. The goal is to objectively break down the degree of symptoms.; The total score of all answers is calculated as follows: 0 to 9 points: Minimally depressive symptoms; 10 to 16 points: Mild depressive symptoms; Between 17 and 29 points: Moderate depressive symptoms; Between 30 and 63 points: Severe depressive symptoms	4 weeks
Secondary	Short Form- 36	Short Form- 36 (SF-36) is a 36-question self-assessment scale consisting of eight subscales. This scale is based on physical function (10 items), role limitations due to physical (4 items) and emotional problems (3 items), pain (2 items), vitality (4 items), social function (2 items), mental health (5 items) and general health (5 items) subscales. Each subscale is scored between 0-100 and "0" indicates the lowest and "100" shows the best quality of life.	4 weeks